1. Field of the Invention
The present invention relates to a balloon catheter designed to be introduced into a body cavity, and more particularly to a balloon catheter including a recess or pocket adapted to receive the end of a separate withdrawable rigid element or finger to aid in the introduction and positioning of the balloon carrying catheter end within a body cavity.
2. Description of Prior Art Including Information Disclosed Under 37 CFR 1.97 AND 1.98
Annular inflatable balloons surrounding the distal end of catheters have been used for many years to retain the distal end of a catheter in position in anatomical organs. Such catheters are commonly used for urinary, thorasic and other applications as well as enema delivery. Those devices, commonly called Foley catheters, are every often employed for urinary catheterization.
Because the distal end of the catheter must be inserted into and properly positioned within the anatomy, it must be sufficiently rigid to be manipulated. However, having a rigid part within many body organs can cause distention of the tissue, such as sphincter muscles or delicate vessels, resulting in the loss of muscle tone or tissue integrity over time.
One such system designed to provide bowel management is disclosed in U.S. Pat. No. 5,569,216 issued Oct. 29, 1996 to Jae H. Kim and entitled “Multipurpose Colostomy Device Having Balloons On An End Thereof.” The Kim system consists of an elongated flexible catheter, the proximal end of which is detachably connected to a waste collection bag. The distal end of the catheter is designed to be inserted through the rectum or stoma into the bowel of the patient.
The distal end of the Kim catheter includes a resilient portion needed for insertion and positioning of the catheter in the bowel. The distal end of the catheter also carries two inflatable balloons, one balloon being situated within the other balloon. The balloons are separately inflatable to block the distal end of the catheter and to seal the catheter to the rectum or stoma, respectively.
Other known rectal catheters include a catheter with a distal end having a rigid portion which can cause soft tissue damage if it remains in the bowel for an extended period of time. However, the rigidity of the distal end of the catheter is needed to permit the introduction and positioning of the device within the bowel.
One possible way to avoid the potential for soft tissue damage resulting from the use of a rigid portion of the distal end of the catheter, and still provide a means to introduce and position the distal end of the catheter within the bowel, is to utilize a catheter with a distal end made entirely of soft, compliant material and a separate elongated rigid introducer element that attaches to the distal end of the catheter during insertion and positioning and then can be detached from the catheter and withdrawn from the bowel. In this way, insertion and proper positioning of the distal end of the catheter is accomplished without the necessity of leaving a rigid part in the body for an extended time.
However, the use of a separate rigid introducer element raises the issue of how to attach the element to the distal end of the catheter during insertion and positioning of the catheter within the bowel and thereafter to detach the element from the catheter once the distal end of the catheter is properly positioned, thereby permitting the element to be withdrawn from the body, without causing any soft tissue damage.
The present invention is a simple and elegant solution to this problem. It involves mounting the balloon on the end of the catheter in a manner that creates a recess or pocket between the catheter wall and balloon wall. The recess or pocket opens toward the proximal end of the catheter. The rigid end of the introducer element is received in the recess to attach it to the catheter. The distal end of the catheter, with the end of the introducer element in the recess, is inserted and positioned within the bowel by manipulating the introducer element. After the catheter is properly positioned in the bowel, the introducer element is withdrawn, detaching it from the catheter as the end of the introducer element slides out of the recess and then out of the bowel. The balloon is inflated to anchor the end of the catheter in position within the bowel, either before or after the introducer element is withdrawn.
Since the distal end of the catheter is made entirely of soft, compliant material, no soft tissue damage can occur from use of the device, even when it remains in place over an extended time period. This system also allows the tip of the rigid introducer element to lie close to the distal end of the balloon allowing the smooth introduction of the catheter. Once in place with the balloon inflated, the pocket is virtually undetectable under the balloon.
The introducer element may be an elongated rigid part, as described below and illustrated in the drawings. Alternatively, since the finger of the health care professional inserting the catheter is elongated and can be rigid, it may be employed as the introducer, for example, in those situations in which an elongated rigid part designed for introduction of the catheter is not available. Accordingly, the term “element” as used in this patent to describe the means used to introduce the catheter should be understood to include either an elongated rigid part designed for introduction of the catheter or the finger of the health care professional.
It is, therefore, a prime object of the present invention to provide a balloon catheter with a distal end formed entirely of soft, compliant materials that is capable of being inserted and positioned within a body cavity with the aid of a detachable and withdrawable elongated rigid element or finger.
It is another object of the present invention to provide such a balloon catheter with a pocket or recess adapted to receive the end of a separate, elongated rigid element during insertion and positioning within the bowel, and thereafter to permit withdrawal of the element.
It is another object of the present invention to provide a balloon catheter which can be inserted and positioned within a body cavity, and remain in place for an extended period of time, without causing soft tissue damage.